Process

Research Reviewed by the DKU IRB

The DKU IRB reviews non-medical research, including behavioral interventions. It does not review medical interventions or any clinical or device studies

Social and behavioral scientists sometimes collect non-invasive physiological samples, for example, they may induce anxiety in a study of effective air filtration methods, and such studies may be reviewed by the DKU IRB. However, studies with the primary goal of collecting biological samples, for example, collecting cortisol, must be reviewed by a biomedical IRB. At present the only biomedical IRB that is authorized to review biomedical research is the Duke University Health System IRB.

(DKU is in the process of identifying institutions in China that may be authorized to review biomedical research.)

The Process

Research with human subjects must be approved before any research activities begin. To secure approval you must submit a form describing your research in detail and attaching appendices such as research instruments and consent form.

The Form

Submit a Request for Protocol Approval to Jing Bai in the Research Support Office. Check the IRB Schedule for meeting dates and submission deadlines.

Assurances

In addition to the description of your research plan, you will be asked to sign assurances about the conduct of the research. For example, you attest that you will conduct the research in accordance with the approved protocol and will report any unanticipated risks of harm to your subjects. The signed assurances may be submitted in one of two ways. You can scan the signed assurances and send them along with the protocol to Jing Bai or you can drop them off in the Research Support Office.

IRB Review

Each protocol will be assigned a primary reviewer. It is possible that your primary reviewer will contact you before the meeting if there are changes that need to be made.

All protocols will be reviewed using criteria developed to ensure the protection of research subjects.

When your protocol is reviewed, there are 4 possible outcomes. The protocol may be (1) approved with no changes, (2) approved pending the receipt of minor modifications, (3) deferred pending receipt of major modifications, or (4) disapproved. If a protocol is deferred that means that the protocol is too incomplete to be reviewed and will need significant revisions. The goal of the IRB is to work with researchers to help them secure approval; therefore, it is very unlikely that any protocols will be disapproved. Modifications, both minor and majorare very commonly requested. This means that final approval can take a significant amount of time. For that reasons please begin this process as early as possible.

Feedback

The outcome and the feedback from the IRB will be sent to you in writing from the Research Support Office in writing within 5 days of the meeting. If you have any questions or comments about the feedback, let the Research Support Office know.

If your protocol needs minor modifications, the revised protocol may be approved by your primary reviewer.

If the protocol needs major modifications, the revised protocol must be reviewed again by the IRB committee at one of their regular meetings.

Approval

When your protocol is approved, you will receive formal notification via email. The notification will include an approved start date. That is when you can begin your research.

End Date

When your protocol is approved you will be given an expiration date, usually 12 months after the approval date. If you wish to continue the research beyond the expiration date, you will need to submit a Request to Renew an Approved Protocol. Requests to Amend an Approved Protocol must be submitted if you anticipate making any changes to your approved protocol. Do not implement changes without IRB Approval.